ASTM_F_2042_-_00_2011.pdf

Designation:F204200(Reapproved 2011)Standard Guide forSilicone Elastomers,Gels,and Foams Used in MedicalApplications Part IICrosslinking and Fabrication1This standard is issued under the fixed designation F2042;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide is intended to educate potential users ofsilicone elastomers,gels and foams relative to their fabricationand processing.It does not provide information relative tosilicone powders,fluids,pressure sensitive adhesives,or othertypes of silicone products.1.2 The information provided is offered to guide users in theselection of appropriate processing conditions for specificmedical device applications.1.3 Formulation and selection of appropriate starting mate-rials is covered in the companion document,F2038 Part I.Thismonograph addresses only the curing,post-curing,and pro-cessing of elastomers,gels and foams as well as how theresulting product is evaluated.1.4 Silicone biocompatibility issues can be addressed atseveral levels,but ultimately the device manufacturer mustassess biological suitability relative to intended use.Biocom-patibility testing may be done on cured elastomers prior to finalfabrication,but the most relevant data are those obtained on thefinished device.Data on selected lots of material are onlyrepresentative when compounding,and fabrication are per-formed under accepted quality systems such as ISO 9001 andcurrent Good Manufacturing Practice Regulations.Extract-ables analyses may also be of interest for investigation ofbiocompatibility,and the procedures for obtaining such datadepend on the goal of the study(see F619,the HIMAMemorandum 7/14/93,and USP 23,for examples of extractionmethods).2.Referenced Documents2.1 ASTM Standards:2D395 Test Methods for Rubber PropertyCompression SetD412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD430 Test Methods for Rubber DeteriorationDynamicFatigueD624 Test Method for Tear Strength of Conventional Vul-canized Rubber and Thermoplastic ElastomersD792 Test Methods for Density and Specific Gravity(Rela-tive Density)of Plastics by DisplacementD813 Test Method for Rubber DeteriorationCrack GrowthD814 Test Method for Rubber PropertyVapor Transmis-sion of Volatile LiquidsD926 Test Method for Rubber PropertyPlasticity andRecovery(Parallel Plate Method)D955 Test Method of Measuring Shrinkage from MoldDimensions of ThermoplasticsD1349 Practice for RubberStandard Conditions for Test-ingD1566 Terminology Relating to RubberD2240 Test Method for Rubber PropertyDurometer Hard-nessF619 Practice for Extraction of Medical PlasticsF719 Practice for Testing Biomaterials in Rabbits for Pri-mary Skin IrritationF720 Practice for Testing Guinea Pigs for ContactAllergens:Guinea Pig Maximization TestF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF813 Practice for Direct Contact Cell Culture Evaluation ofMaterials for Medical DevicesF981 Practice for Assessment of Compatibility of Biomate-rials for Surgical Implants with Respect to Effect ofMaterials on Muscle and BoneF1905 Practice For Selecting Tests for Determining thePropensity of Materials to Cause Immunotoxicity(With-drawn 2011)3F1906 Practice for Evaluation of Immune Responses InBiocompatibility Testing Using ELISATests,LymphocyteProliferation,and Cell Migration(Withdrawn 2011)3F1984 Practice for Testing for Whole Complement Activa-tion in Serum by Solid Materials1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.11 on Polymeric Materials.Current edition approved Dec.1,2011.Published January 2012.Originallyapproved in 2000.Last previous edition approved in 2005 as F2042 00(2005).DOI:10.1520/F2042-00R11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 F2038 Guide for Silicone Elastomers,Gels,and Foams Usedin Medical Applications Part IFormulations and Un-cured Materials2.2 Other Biocompatibility Standards:United States Pharmacopeia,current edition(appropriatemonographs may include:,)4FDA Department of Health and Human Services GeneralProgram Memorandum#G951,May 1,1995:Use ofInternational Standard ISO-10993,Biological Evaluationof Medical Devices Part I:Evaluation and Testing5ANSI/AAMI 109931 Biological Evaluation of MedicalDevices,Part I:Guidance on Selection of Tests6HIMA Me